# K231181: bright CT

- Pathway: 510(k) (Special)
- Applicant: Dentium Co., Ltd (Ict Branch)
- Decided: Dec 14, 2023 after 232 days
- Product code: OAS (X-Ray, Tomography, Computed, Dental)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K193139 (2020). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200271: rainbow CT, Dentium Co., Ltd (Ict Branch) (2021) Summary page 4.

## Indications for use
bright CT is a computed tomography x-ray system intended to produce 3D, panoramic, and cephalometric diagnostic images of the maxillofacial areas for treatment planning for adult and pediatric patients. The device is operated and used by physicians, dentists, and x-ray technicians. Rainbow 3D Image Viewer software features functions for acquiring, saving, searching, displaying, diagnosing and sending digital X-ray image data in dental practices and clinics.

Source page: https://510kreport.com/device/K231181
Methodology: https://510kreport.com/methodology